Critical Illness Clinical Trial
Official title:
A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance
The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.
The drug being tested in this study is called TAK-954. The study will assess the treatment
effect of intravenous TAK-954 in improving average daily protein adequacy received through
enteral nutrition in critically ill participants with EFI.
The study will enroll approximately 200 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to one of the 4 treatment groups -which will remain
undisclosed to the participant and study doctor during the study (unless there is an urgent
medical need):
- Group A: TAK-954 0.1 mg
- Group B: TAK-954 0.3 mg
- Group C: TAK-954 1 mg
- Group D: Metoclopramide 10 mg
This multi-center trial will be conducted in the United States, United Kingdom, Australia and
Canada. The overall duration of treatment in this study is maximum of 14 days while in
hospital. Participants will be contacted by telephone 30 and 90 days after receiving their
last dose of study drug for a follow-up assessment.
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